CUSA® Clarity

Basic Information

• Brand Name: CUSA® Clarity
• Primary DI: 10381780536352
• Version / Model: C7421SEA
• Catalog Number: C7421SEA
• Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• Labeler DUNS: 989925396
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-15
• Public Version: 1
• Public Version Date: 2022-11-23
• Public Version Status: New
• Public Device Record Key: 47e88327-f077-4080-8f81-643463a04706

Device Description

CUSA Clarity 23kHz Single-Sided Bone Tip (Single Pack)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LBK	Neurosurgical ultrasonic instruments	Unknown		U
LFL	Instrument, ultrasonic surgical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
60718	Hard-tissue ultrasonic surgical system handpiece tip	A sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece to amplify and deliver ultrasonic energy to mechanically fragment and cut bone upon contact during an orthopaedic surgical procedure (e.g., spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It is available in a variety of sizes and forms (e.g., blade, rasp), and is not intended to be held directly; a channel for surgical waste aspiration and a covering sleeve for delivery of irrigation solution may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780536352	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K221835	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 millibar
• Type: Handling Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -18 – 60 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 500 – 1060 millibar
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry; Do not use if package is damaged
• Type: Storage Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity